RecruitingPhase 1Phase 2NCT06422923

A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)

A Phase 1/2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Temporal Lobe Epilepsy (MTLE)


Sponsor

Neurona Therapeutics

Enrollment

10 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called NRTX-1001 for people with epilepsy, temporal lobe. The study is currently recruiting participants at 17 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNRTX-1001

Biological: NRTX-1001 is an inhibitory neural cell therapy investigational product. It is derived from a human stem cell line that has been converted into high-purity inhibitory interneurons that produce GABA. NRTX-1001 is intended to persist long-term and not require repeated administration.


Locations(17)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of Southern California Keck Hospital

Los Angeles, California, United States

UC Irvine Medical Center

Orange, California, United States

Stanford University

Palo Alto, California, United States

University of California San Diego

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Chicago

Chicago, Illinois, United States

University of Iowa Health Care

Iowa City, Iowa, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Duke University Hospital

Durham, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

UTHealth Houston

Houston, Texas, United States

UVA Health University Medical Center

Charlottesville, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06422923


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